The Efficacy and Safety of Treatment with Telitacicept in Antineutrophil Cytoplasmic Antibody-associated Nephritis (AAGN)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 10, 2024

Primary Completion Date

December 30, 2025

Study Completion Date

October 30, 2026

Conditions
Antineutrophil Cytoplasmic Antibody (ANCA)-associated Nephritis (AAGN)
Interventions
DRUG

Telitacicept 160mg

Telitacicept for Injection combined with standard therapy (Prednisone and Cyclophosphamide) for the treatment of ANCA-associated nephritis (AAGN).

DRUG

Prednisone (and methylprednisolone)

Methylprednisone shock therapy (500mg, 3 times), followed by Prednisone (1 mg·kg·d and a pre-determined tapering guideline \[PEXIVAS regimen\]).

DRUG

Cyclophosphamide

Cyclophosphamide, intravenous injection, once every 2 to 3 weeks, 0.75 g/m² each time, the maximum cumulative dose of 8g

Trial Locations (1)

Unknown

Renmin hospital of Wuhan University, Wuhan

All Listed Sponsors
lead

Renmin Hospital of Wuhan University

OTHER

NCT06656962 - The Efficacy and Safety of Treatment with Telitacicept in Antineutrophil Cytoplasmic Antibody-associated Nephritis (AAGN) | Biotech Hunter | Biotech Hunter